EU Qualified Person
Budapest
On-site 1–3 év szakmai tapasztalat 3–5 év szakmai tapasztalat 5–10 év szakmai tapasztalat
Short Description
Our partner is a leading international pharmaceutical company specializing in the development and commercialization of innovative and biologic medicines. With a strong global presence, the company is committed to improving patient access to high-quality therapies and advancing healthcare solutions worldwide. We are currently seeking an experienced professional to join their team as an EU Qualified Person.
Description
- Lead and support MIA variation submissions and regulatory updates in Hungary
- Prepare key documentation (QMS, SMF, QP declarations) and support GMP inspection readiness
- Perform EU QP batch certification and release activities in line with Annex 16 requirements
- Review batch documentation and ensure compliance with marketing authorisation requirements
- Oversee quality system processes including deviations, CAPA, and change control
- Participate in PQR/APQR activities
- Collaborate with global and local QA, RA, and manufacturing/CMO partners
- Support product launches and supply continuity
Requirements
- Degree in Biochemistry, Pharmacy, or related field
- Eligibility as EU Qualified Person (QP)
- 2–10 years of experience in pharmaceutical Quality Assurance
- Strong knowledge of EU GMP guidelines, including Annex 1 and Annex 16
- Experience with batch certification, audits, and validation activities
- Experience with MIA variations is an advantage
- Experience in sterile manufacturing is an advantage
- Fluent English is required; Hungarian is preferred, additional EU language is an advantage
Offer
- Competitive salary and annual performance bonus
- Cafeteria, telephone and meal allowance, health insurance, AYCM membership
- Travel support or parking place
- Opportunity to work in a globally recognized biopharma company
- International, supportive and family-like working environment
- Full-time, permanent contract with immediate start
- Home office possibility
- Budapest
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